multicentral preventive antibiotics with cystectomy within enhanced recovery after surgery

Conditions: Bladder Cancer

Summary: the current usage of antibiotic prophylaxis (ap) in radical cystectomy (rc) is aimed to reducing the incidence of surgical site infections and incidence of unnecessary prescribing of antibiotics. there are a huge number of different ap protocols according to urological associations. however, there is no convincing evidence to support variations and duration of ap which requires a randomized clinical trial on ap when performing variants of rc with uroderivation. research hypothesis: the use of prolonged antibiotic prophylaxis (5 days), depending on the glomerular filtration rate, does not affect the incidence of postoperative complications.


Eligibility criteria:
inclusion criteria: * histologically confirmed diagnosis of very high risk non muscle-invasive bladder carcinoma (ct1nomo) or muscle-invasive bladder carcinoma (ct2-t4nxm0) with or without neoadjuvant therapy (chemotherapy or immunotherapy are both possible); * patient should be eligible for radical cystectomy (rc) + pelvic lymph node dissection (plnd), and agreement to undergo curative intent standard rc + plnd (including prostatectomy or hysterectomy if applicable) according to surgeon opinion; * pelvic lymph node dissection is engaged in two possible variants: extended level to intersection of ureter and iliac vessels; superextended level - up to aortic bifurcation; * urinary diversion is engaged in two possible variants: orthotopic diversion (j- or u-pouch reservoirs), heterotopic diversion in the mainz-i modification, bricker; * male or female is at least 18 years old at the time of signing the informed consent form; * female patient is eligible to participate if she is not pregnant, not breastfeeding; * ecog performance status of 0 or 1; * adequate organ function (in accordance with laboratory standards); * used valid protocol for enhanced recovery after surgery (eras protocol) at hospital (oncourological department); exclusion criteria: * known additional non-urothelial malignancy that is progressing or has required active anticancer treatment ≤3 years of study randomization, with certain exceptions; * diagnosis of immunodeficiency or receipt of chronic systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior the first dose of study drug; * replacement doses of corticosteroids are permitted for participants with adrenal insufficiency; * evidences of uncontrolled diseases (diabetes mellites, noninfectious pneumonitis that required steroids, et.) or any conditions which interfere with the conduct of the research procedures according to doctor opinion; * presence of 2 or more criteria for systemic inflammatory response syndrome (sirs) at the time of the patient's admission to the hospital (assessment of these factors 3-7 days before randomization): * temperature ≥ 38˚с or ≤ 36˚с; * heart rate (hr) ≥ 90 / min; * respiratory rate \< 20/min or hyperventilation (pa co2 ≤ 32 mm hg); * blood leukocytes \>12 ∙ 109 / l or \ 10% * prohibited urinary diversion when planning surgery and signing voluntary consent: diversion into continuous intestine (ureterosigmostomy, mainz-pouch ii operation); * inadequate organ function: * neutrophils \<1.5 x 10 \^ 9 / l * platelets \<100 x 10 \^ 9 / l * alt\> 3 x vgn * ast\> 3 x vgn * bilirubin\> 1.5 x uln * gfr level \<35 ml / min

Keywords: radical cystectomy antibiotic prophylaxis eras protocol muscle-invasive bladder cancer urinary diversion